Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse (NCT03400787) | Clinical Trial Compass
CompletedNot Applicable
Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
United States137 participantsStarted 2017-11-28
Plain-language summary
The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Subjects must meet the following criteria to be included in the study:
1. Adults aged 18 and above;
2. Understands and provides written informed consent;
3. Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years;
4. In good general health as evidenced by medical history;
5. NOSE score ≥55;
6. Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver;
7. Nasal and facial anatomy appropriate to receive the Latera Implant;
8. Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability.
Subjects meeting any one of the following criteria will be excluded for the study:
1. Unable to tolerate or not a candidate for procedures performed under local anesthesia;
2. Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction;
3. Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure;
4. FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months;
5. Any other rhinop…